UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002045 |
|---|---|
| Receipt number | R000002459 |
| Scientific Title | A multidisciplinary intervention care program to prevent adverse health outcomes for the dependent community-dwelling elderly: a cluster randomized controlled trial |
| Date of disclosure of the study information | 2009/06/05 |
| Last modified on | 2012/12/04 16:59:22 |
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Basic information
Public title
A multidisciplinary intervention care program to prevent adverse health outcomes for the dependent community-dwelling elderly: a cluster randomized controlled trial
Acronym
A multidisciplinary intervention care program to prevent adverse health outcomes for the dependent community-dwelling elderly: a cluster randomized controlled trial
Scientific Title
A multidisciplinary intervention care program to prevent adverse health outcomes for the dependent community-dwelling elderly: a cluster randomized controlled trial
Scientific Title:Acronym
A multidisciplinary intervention care program to prevent adverse health outcomes for the dependent community-dwelling elderly: a cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Community-dwelling elderly (age 65 years or older) with physical or mental disability in some degree, who are eligible for the long-term care insurance program
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of a risk-oriented care management program through care managers on better health outcomes for community-dwelling dependent elderly and their caregivers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality and hospitalization during 2-year follow-up
Key secondary outcomes
long-term care placement and overall discontinuation of living at home during 2-year follow-up, and adverse health outcomes of caregivers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Care managers from the Nagoya City Health Care Service Foundation for Older People, which has 16 care-managing centers, are randomly assigned to two groups in each center, intervention and usual care management groups. The control care managers provide usual care plan to participants (care recipients and caregivers).
Interventions/Control_2
Care managers from the Nagoya City Health Care Service Foundation for Older People, which has 16 care-managing centers, are randomly assigned to two groups in each center, intervention and usual care management groups. Care managers in the intervention group conduct the comprehensive risk assessment for 5 domains including falls, aspiration pneumonia, malnutrition, medication management, and caregiver burden or inadequate informal care every 3 month intervals. The care managers provide the risk-oriented care program in addition to usual care program to care recipients and caregivers for 2 years.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling elderly with physical or mental disability in some degree, who were eligible for the Long-Term Care Insurance program, lived in Nagoya City, Japan, and received care management service from the Nagoya City Health Care Service Foundation for Older People, and their caregivers
Key exclusion criteria
no exclusion criteria
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Kuzuya |
Organization
Nagoya University Graduate School of Medicine
Division name
Geriatrics
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2364
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Kuzuya |
Organization
Nagoya University Graduate School of Medicine
Division name
Geriatrics
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2364
Homepage URL
Sponsor or person
Institute
Department of Geriatrics, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research of The Ministry of Education, Culuture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
the Nagoya City Health Care Service Foundation for Older People
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 04 | Day |
Last modified on
| 2012 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002459
